Benzinga | Mar 22, 2021 04:02PM EDT

Chiasma Offers Long-Term Safety, Efficacy Data From Open-Label Extension Study Of Its Phase 3 Trial Of MYCAPSSA Candidate: '93% of all patients who enrolled as a responder to MYCAPSSA maintained their biochemical response'

Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA(r) as the first oral therapy for the treatment of acromegaly, today presented long-term safety and efficacy data from the first 48 weeks of the open-label extension (OLE) of the Phase 3 CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) trial of MYCAPSSA (octreotide capsules) at the Endocrine Society's annual meeting, ENDO 2021, being held virtually March 20-23, 2021.

"These long-term safety and efficacy data demonstrate that MYCAPSSA maintains insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly who previously required monthly injections for their disease," said Susan L. Samson, M.D., Ph.D., FRCPC, FACE, principal investigator of the trial. "The fact that 90% of the patients receiving MYCAPSSA in the CHIASMA OPTIMAL trial elected to enroll in the OLE demonstrates strong patient preference for MYCAPSSA."

Results from the ongoing OLE study show that the average IGF-1 levels of all patients (n=19) treated with MYCAPSSA who completed the double-blind placebo-controlled (DPC) period in the CHIASMA OPTIMAL trial and continued into the OLE were maintained within normal limits at the end of the 48-week OLE period (0.91 at baseline and 0.90 ? upper limit of normal (ULN) at week 48). All patients who responded to MYCAPSSA (IGF within normal limits) during the DPC period and enrolled in the OLE (n=14) completed the 48-week period and 93% (13/14) maintained their IGF-1 response within the normal limit at the end of this period. The safety profile of MYCAPSSA observed during the OLE was generally consistent with the safety observed in the CHIASMA OPTIMAL trial with the number of adverse events decreasing over the time of the OLE.

Raj Kannan, Chief Executive Officer of Chiasma, added, "The long-term durability of response seen with the 48-week open label extension study further supports our belief in MYCAPSSA's potential to become the new standard of pharmacological care for patients with acromegaly."